The DAIDS Protocol Registration Office (PRO) at the RSC receives and processes all protocol registration materials submitted by sites participating in DAIDS-supported and/or sponsored clinical trials. They work closely with the DAIDS Protocol Registration Team (PRT) to establish internal procedures and processes.

The DAIDS protocol registration process verifies that sites have received the necessary Institutional Review Board (IRB)/ Ethics Committee (EC) and other applicable Regulatory Entity (RE)/Approving Entity approvals and have provided to DAIDS all documentation pertaining to investigator qualifications and responsibilities that are required by the U.S. federal regulations and the National Institutes of Health (NIH). The DAIDS protocol registration process also verifies that site-specific informed consent forms contain the necessary information to comply with U.S. federal regulations.

Guidance Regarding DAIDS Deregistration Process

Protocol Registration ChecklistThis document must be submitted with each submission made through the electronic protocol registration (EPR) mailbox to the DAIDS PRO.

Protocol Registration Checklist - April 2010

Form FDA 1572, Statement of InvestigatorA protocol specific Form FDA 1572 must be submitted with each initial protocol registration submission for protocols conducted under an IND.

Financial Disclosure FormProcess for collection of Financial Disclosure Forms for all investigators and sub-investigators listed on Form FDA 1572.

DAIDS Financial Disclosure Guidance

Financial Disclosure Forms for ACTG

Financial Disclosure Form for HPTN

Financial Disclosure Form for HVTN

Financial Disclosure Form for IMPAACT

Financial Disclosure Form for MTN

DAIDS Investigator of Record (IoR) FormA protocol specific DAIDS IoR Form must be submitted with each initial protocol registration submission for protocols NOT conducted under an IND.

This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).